1. Field of the Invention
This invention relates generally to clinical trials and more specifically to the workflow, planning, execution, and tracking of a clinical trial and the management of data processing tasks during a clinical trial.
2. Related Art
Obtaining approval for a therapeutic product (e.g., a medical device, a pharmaceutical product such as a drug, etc.) requires a clinical trial in which the therapeutic product is tested on human subjects to validate the product's safety and efficacy for its intended purpose. To ensure that the results of the clinical trials are reliable and that results are reproducible, many clinical trials are often multi-site and/or multinational operations which typically require substantial planning and oversight to run efficiently. For example, a clinical trial may involve hundreds or thousands of patients recruited worldwide, and a central management service may be employed to manage various aspects of the clinical trial.
As clinical trials continue to grow in complexity and global scope, the processes required to manage such studies are becoming more complex and the volume of data generated by the numerous sites, organizations, and systems involved in large clinical trials increases. To manage this added complexity investigational sites often employ multiple technology systems within a single clinical trial to perform their responsibilities, with each of the systems being designed to provide a specific function to facilitate the operation of the clinical trial. For example, one application may be designed for data acquisition and management, whereas another application may be designed for trial control and logistics (e.g., randomization and trial supply management). Other applications may be designed for planning and administration or data analysis and reporting. Individual applications are often selected based on their own relative merits in comparison to the alternatives, rather than being selected based on their ability to integrate with other applications.